MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-05-18 for SYNTHAFAX APTT REAGENT 735820 manufactured by Ortho Clinical Diagnostics Inc. Hemoliance Div.
[131202]
Pt sample that had an aptt results of 26 seconds with synthafax reagent (lot no. Sfx107) was also sent to two other labs using this lot of reagent. Results were 28. 9 and 28. 6. Pt was not responding to heparin therapy and was given a 2nd bolus of heparin. The lab cannot confirm that this pt had complications due to the additional heparin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431530-1999-00001 |
| MDR Report Key | 223904 |
| Report Source | 05 |
| Date Received | 1999-05-18 |
| Date of Report | 1999-05-18 |
| Date of Event | 1999-04-01 |
| Date Mfgr Received | 1999-04-06 |
| Device Manufacturer Date | 1998-09-01 |
| Date Added to Maude | 1999-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNTHAFAX APTT REAGENT |
| Generic Name | ACTIVATED PARTIAL THROMBOPLASTIN TIME |
| Product Code | GFO |
| Date Received | 1999-05-18 |
| Returned To Mfg | 1999-04-14 |
| Model Number | NA |
| Catalog Number | 735820 |
| Lot Number | SFX107 |
| ID Number | NA |
| Device Expiration Date | 2000-09-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 217140 |
| Manufacturer | ORTHO CLINICAL DIAGNOSTICS INC. HEMOLIANCE DIV |
| Manufacturer Address | 1001 U.S. HWY 202 RARITAN NJ 088690606 US |
| Baseline Brand Name | SYNTHAFAX APTT REAGENT |
| Baseline Generic Name | ACTIVATED PARTIAL THROBOPLASTIN TIME |
| Baseline Model No | NA |
| Baseline Catalog No | 735820 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-05-18 |